The use of oral ganciclovir in the treatment of cytomegalovirus retinitis in patients with AIDS.

OBJECTIVE

To recommend the appropriate use of oral ganciclovir as an alternative to intravenous (i.v.) maintenance therapy for cytomegalovirus (CMV) retinitis in patients with AIDS.

OPTIONS

i.v. infusion of ganciclovir and foscarnet have been the only approved choices for maintenance therapy until the introduction of oral ganciclovir.

OUTCOMES

Ease of administering maintenance therapy and improved quality of life for patients with AIDS.

VALUES

The medical advisory group comprised physicians treating patients with AIDS therapy. Ease of administration of maintenance therapy and quality of patients' lives were considered important.

BENEFITS, HARMS AND COSTS: Oral ganciclovir is a safe and convenient alternative to i.v. maintenance therapy for patients with CMV retinitis. However, its low bio-availability precludes its use for induction therapy and necessitates careful monitoring for compliance. Compared with i.v. administration of ganciclovir, oral maintenance therapy is cost effective.

EVIDENCE

Evidence for the guidelines was gathered from data presented at a symposium on CMV retinitis and oral ganciclovir, clinical trials of oral ganciclovir and input from a visiting expert. It was presented at a meeting of the advisory board whose members are involved in the care of patients with AIDS and the management of CMV retinitis. The guidelines were approved by each member of the advisory board.

RECOMMENDATIONS

Diagnosis, treatment and follow-up of CMV retinitis should always be in consultation with an ophthalmologist who is experienced in treating this disease. The patient should be fully informed about the limitations of the oral form of ganciclovir; he or she should be involved in decision making and carefully monitored. Oral ganciclovir should not be used for induction therapy or for maintenance therapy in high-risk patients.

VALIDATION

Similar guidelines have been produced in England where the drug has been available since January 1995.

SPONSOR

The deliberations of the advisory board and the preparation of this report were funded through an educational grant from Hoffmann-La Roche (Canada).